Reducing nicotine in cigarettes: Challenges and opportunities

In a July 28 announcement, Dr. Scott Gottlieb, recently appointed as the 23rd commissioner of the U.S. Food and Drug Administration (FDA), committed his agency to introduce a new guiding philosophy for the regulation of tobacco and nicotine. The associated news release set out the agency’s desire for a “new comprehensive plan for tobacco and nicotine regulation” and for an “approach [that] places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts.”

The focus on nicotine, rather than tobacco, is an effort to address the underlying cause of smoking-related diseases and deaths – that is, that people smoke tobacco primarily to consume nicotine. By lowering nicotine levels in cigarettes to nonaddictive levels, we could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.

This approach is at least internally coherent and it could work if several major assumptions about how the market will react to this measure turn out to be correct. However, this is a very dramatic intervention in the $94 billion U.S. market for cigarettes, in which the main product, traditional full-nicotine cigarettes, would effectively be removed from the market.

The severe challenge for FDA is that it really does not know, and perhaps cannot know, how the market will react to such an intervention. Nor do we know how those affected as consumers, suppliers and law enforcement will react to the criminalization of a personal behavior practiced by roughly 38 million Americans and that has always been legal. In all likelihood, there will be both cultural and personal responses. For example, it is quite possible that, as hoped, teenagers will simply stop smoking or never get hooked in the first place. However, it is also possible that they will simply source full-nicotine cigarettes from a resultant black market. The bottom line is that the FDA cannot know which one will predominate.

The risks of such potential for unintended, real-world consequences has been recognized within the FDA. Showing appropriate caution, Gottlieb charged the agency to “begin a public dialogue”about lowering nicotine levels in combustible cigarettes and to consider the potential for unintended consequences that may arise from such rulemaking:

I’ve also asked CTP [Center for Tobacco Products] to explore the potential for any adverse effects from reducing nicotine levels, especially the possibility of a black market for higher nicotine products. And we need to understand what role, if any, the availability of newer forms of nicotine delivery may play in reducing those adverse effects.

Very little of the research undertaken so far provides any insight into the way the market will respond, nor does it help to elucidate the nature and extent of unintended consequences. For this reason, the outcome of this initial dialogue will likely be a list of unanswered, and perhaps unanswerable, questions about what effects, good or bad, such a huge intervention might have. For these reasons, the present study seeks to explore some of the issues facing the FDA and proponents of the nicotine-reduction strategy and to suggest a potential way forward.